Analysis of the Regulatory and Reimbursement landscape of Biosimilars

INTRODUCTION A biosimilar is a biological medicine that is developed to be similar to an existing biologic, with the active component of the biosimilar being essentially the same biological substance as its reference product. A wide variety of biosimilars are available, from relatively small molecules such as human insulin or erythropoietin, to complex molecules such as monoclonal antibodies. Biosimilars are known by different terms in different regions; in Canada they are known as subsequent entry biologics [1], and they are also called follow-on biologics, a term that is commonly used in the United States [2]. Although the terminology varies by jurisdiction, in highly regulated markets, the term always refers to a biologic product that is similar to an already approved reference medicine. Due to the complexity of biological substances and the nature of their production methods, there will be minor differences between the biosimilar and the reference biologic, and both products will have a degree of natural variability. There are strict guidelines in place for the regulatory assessment of biosimilars, and according to these guidelines, biosimilars may have an acceptable level of variability from the reference product, but the data must show that the biosimilar and the reference product do not have any meaningful differences in terms of quality, safety, and efficacy [1,3,4].